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The Lymphoma Hub has previously reported on the interim analysis of the ELARA trial (NCT03568461) for adult patients with relapsed/refractory (R/R) follicular lymphoma (FL). This analysis was presented during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition by the Nathan Fowler, a Lymphoma Hub Executive Steering Committee member. Recently, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, the primary analysis of the phase II ELARA trial was presented by Stephen Schuster. Here we provide a summary of the updated findings.
ELARA is a single-arm, multicenter, phase II study evaluating the efficacy and safety of tisagenlecleucel (tisa-cel), a chimeric antigen receptor (CAR) T-cell therapy, in patients with R/R FL; further details can be found here.
The primary endpoint was complete response rate assessed by an Independent Review Committee based on the 2014 Lugano classification. The secondary endpoints included overall response rate, duration of response, progression-free survival (PFS), overall survival, and cellular kinetics.
A total of 97 patients were enrolled, with a median age of 57 years (range, 29–73 years). The eligible patients were heavily pretreated, with a median of four prior therapies (range, 2–13). Approximately 76% of patients were refractory to ≥2 regimens (Table 1). The median infused dose of tisa-cel was 2.06 × 108 CAR+ viable T cells.
Table 1. Baseline characteristics*
Characteristic, % |
Total |
---|---|
ECOG PS |
|
0 |
58 |
1 |
38 |
2 |
4 |
Prior therapies |
|
≥5 |
28 |
Auto-HSCT |
36 |
Anti-CD20 mAb and alkylating agents |
65 |
PI3K inhibitors |
21 |
Lenalidomide and rituximab |
17 |
Stage III-IV disease |
85 |
FLIPI ≥3 |
60 |
Refractory to last line of therapy |
78 |
Refractory to ≥2 regimens |
76 |
Auto-HSCT, autologous hematopoietic stem cell transplantation; ECOG PS, European Cooperative Oncology Group performance status; FLIPI, follicular lymphoma international prognostic factor index; mAb, monoclonal antibody; PI3K, phosphoinositide 3-kinase. |
Table 2. IRC-assessed response rate*
Response rate, % |
Total |
---|---|
CR |
66† (95% CI, 56–75) |
PR |
20 |
ORR (CR+PR) |
86 (95% CI, 78–92) |
CI, confidence interval; CR, complete response; IRC, Independent Review Committee; ORR, overall response rate; PR, partial response. |
Table 3. AEs of special interest observed for all patients*
AE of special interest (within 8 weeks of infusion), % |
All grades |
Grade ≥3 |
---|---|---|
CRS |
49 |
0 |
Neurological adverse reactions |
9 |
1 |
Infections |
19 |
5 |
Hematologic disorders including cytopenia |
|
|
Neutropenia† |
31 |
28 |
Anemia |
25 |
13 |
Thrombocytopenia |
17 |
9 |
Tumor lysis syndrome |
1 |
1 |
Prolonged depletion‡ of B cells and/or agammaglobulinemia (IgG <4 g/L) |
10 |
0 |
AE, adverse event; CRS, cytokine release syndrome. |
The study demonstrated that tisa-cel had high rates of durable responses and these responses were effective and comparable across high-risk subgroups. No cases of high-grade CRS, no treatment related mortality, and low levels of neurotoxicity were consistent with the established favorable safety profile of tisa-cel. The positive findings from the study warrant further investigation of tisa-cel as a treatment for adult patients with R/R FL following ≥2 lines of therapy.
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